Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 / Notices 36915

Animal Subjects

If the proposed project involves

research on animal subjects, the

applicant must comply with the ‘‘PHS

Policy on Humane Care and Use of

Laboratory Animals by Awardee

Institutions.’’ An applicant organization

proposing to use vertebrate animals in

PHS-supported activities must file an

Animal Welfare Assurance with the

Office for Protection from Research

Risks at the National Institutes of

Health.

Application Submission and Deadline

Applicants are strongly encouraged to

submit the original and five complete

copies of application PHS Form 398

(Revised 5/95, OMB Control Number

0925–0001) to Sharron P. Orum, Grants

Management Officer, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300,

Mailstop E–18, Atlanta, GA 30305, on or

before October 1, 1998.

1. Deadline: Applications shall be

considered as meeting the deadline if

they are either:

a. Received on or before the deadline

date; or

b. Sent on or before the deadline date

and received in time for submission to

the objective review group. (Applicants

must request a legibly dated U.S. Postal

Service postmark or obtain a legibly

dated receipt from a commercial carrier

or U.S. Postal Service. Private metered

postmarks shall not be acceptable as

proof of timely mailing.)

2. Late Applications: Applications

which do not meet the criteria in 1.a. or

1.b. above are considered late

applications. Late applications will not

be considered and will be returned to

the applicant.

Where To Obtain Additional

Information

To receive additional written

information and to request an

application kit, call 1–888–GRANTS (1–

888–472–6874). You will be asked to

leave your name and address and will

be instructed to identify the

Announcement number of interest.

(Please refer to Announcement Number

99003.) You will receive a complete

program description, information on

application procedures and application

forms.

If you have questions after reviewing

the contents of all the documents,

business management technical

assistance may be obtained from Oppie

M. Byrd, Grants Management Specialist,

Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road, NE.,

Room 314, Mailstop E–18, Atlanta, GA

30305, telephone (404) 842–6546,

Facsimile (404) 842–6513, Internet

oxb3@cdc.gov. Programmatic technical

assistance may be obtained from Anne

Schuchat, M.D., National Center for

Infectious Diseases, Division of Bacterial

and Mycotic Diseases, Centers for

Disease Control and Prevention (CDC),

1600 Clifton Road, NE., Mailstop C–23,

Atlanta, GA 30333, telephone (404)

639–4720, Internet acs1@cdc.gov.

Please refer to Announcement

Number 99003 when requesting

information regarding this program.

You may obtain this announcement

from one of two Internet sites on the

actual publication date: CDC’s Home

Page at http://www.cdc.gov or at the

Government Printing Office Home Page

(including free on-line access to the

Federal Register at http://

www.access.gpo.gov).

Potential applicants may obtain a

copy of Healthy People 2000 (Full

Report, Stock No. 017–001–00474–0) or

Healthy People 2000 (Summary Report,

Stock No. 017–001–00473–1) referenced

in the Introduction through the

Superintendent of Documents,

Government Printing Office,

Washington, D.C. 20402–9325,

telephone (202) 512–1800.

Dated: July 1, 1998.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 98–18018 Filed 7–7–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Announcement Number 99005]

Applied Research Program in

Emerging Infections Correlation of

Environmental Monitoring of Microbial

Agents With Disease Control; Notice of

Availability of Funds for Fiscal Year

1999

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1999

funds for competitive grants and/or

cooperative agreements to support

applied research on emerging infections.

This announcement specifically

addresses the correlation of

environmental monitoring of microbial

agents with disease control.

CDC is committed to achieving the

health promotion and disease

prevention objectives of Healthy People

2000, a national activity to reduce

morbidity and mortality and improve

the quality of life. This announcement

is related to the priority area of

Immunization and Infectious Diseases.

(For ordering a copy of Healthy People

2000, see the section Where to Obtain

Additional Information.)

Authority

This program is authorized under

Sections 301(a) and 317(k)(2) of the

Public Health Service Act, as amended

[42 U.S.C. 241(a) and 247b(k)(2)].

Smoke-Free Workplace

CDC strongly encourages all grant

recipients to provide a smoke-free

workplace and to promote the non-use

of all tobacco products, and Public Law

103–227, the Pro-Children’s Act of 1994,

prohibits smoking in certain facilities

that receive Federal funds in which

education, library, day-care, health-care

and early childhood development

services are provided to children.

Eligible Applicants

Applications may be submitted by

public and private nonprofit

organizations and governments and

their agencies. Thus, universities,

colleges, research institutions, hospitals,

other public and private nonprofit

organizations, including State and local

governments or their bona fide agents

are eligible to apply.

Note: An organization described in Section

501(c)(4) of the Internal Revenue Code of

1986 which engages in lobbying activities

shall not be eligible to receive Federal funds

constituting an award, grant, contract, loan,

or any other form.

Only one application will be accepted

from any single applicant, organization,

government, or agency.

Availability of Funds

Approximately $500,000 is available

in FY 1999 to fund one to three awards,

ranging from $100,000 to $500,000. It is

expected the award(s) will begin on or

about March 1, 1999, and will be made

for a 12-month budget period within a

project period of up to three years. (The

funding amounts listed above are for the

first 12-month budget period and

include both direct and indirect costs.)

Funding estimates may vary and are

subject to change.

Continuation awards within an

approved project period will be made

on the basis of satisfactory progress and

availability of funds.
36916 Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 / Notices

Determination of Which Instrument to

Use

Applicants must specify the type of

award for which they are applying,

either grant or cooperative agreement.

CDC will review the applications in

accordance with the evaluation criteria.

Before issuing awards, CDC will

determine whether a grant or

cooperative agreement is the

appropriate instrument based upon the

need for substantial CDC involvement in

the project.

To assist applicants in making a

determination as to which type of award

to apply for, the following information

is provided:

1. Grants

A research project grant is one in

which substantial programmatic

involvement by CDC is not anticipated

by the recipient during the project

period. Applicants for grants must

demonstrate an ability to conduct the

proposed research with minimal

assistance, other than financial support,

from CDC. This would include

possessing sufficient resources for

clinical, laboratory, and data

management services and a level of

scientific expertise to achieve the

objectives described in their research

proposal without substantial technical

assistance from CDC.

2. Cooperative Agreements

A research project cooperative

agreement is one in which CDC will

assist recipients in conducting the

proposed research. The application

should be presented in a manner that

demonstrates the applicant’s ability to

address the research problem in a

collaborative manner with CDC.

Use of Funds

Restrictions on Lobbying

Applicants should be aware of

restrictions on the use of HHS funds for

lobbying of Federal or State legislative

bodies. Under the provisions of 31

U.S.C. Section 1352 (which has been in

effect since December 23, 1989),

recipients (and their subtier contractors)

are prohibited from using appropriated

Federal funds (other than profits from a

Federal contract) for lobbying Congress

or any Federal agency in connection

with the award of a particular contract,

grant; cooperative agreement, or loan.

This includes grants/cooperative

agreements that, in whole or in part,

involve conferences for which Federal

funds cannot be used directly or

indirectly to encourage participants to

lobby or to instruct participants on how

to lobby.

In addition, the FY 1998 ‘‘Department

of Labor, Health and Human Services,

and Education, and Related Agencies

Appropriations Act’’ (Public Law 105–

78) states in Section 503 (a) and (b) that

no part of any appropriation contained

in this Act shall be used, other than for

normal and recognized executivelegislative relations, for publicity or

propaganda purposes, for the

preparation, distribution, or use of any

kit, pamphlet, booklet, publication,

radio, television, or video presentation

designed to support or defeat legislation

pending before the Congress or any

State legislature, except in presentation

to the Congress or any State legislature

itself. No part of any appropriation

contained in this Act shall be used to

pay the salary or expenses of any grant

or contract recipient, or agent acting for

such recipient, related to any activity

designed to influence legislation or

appropriations pending before the

Congress or any State legislature.

Background

Once expected to be eliminated as a

public health problem, infectious

diseases remain the leading cause of

death worldwide. In the United States

(U.S.) and elsewhere, infectious diseases

increasingly threaten public health and

contribute significantly to the escalating

costs of health care.

In 1992, the Institute of Medicine of

the National Academy of Sciences

published a report entitled Emerging

Infections, Microbial Threats to Health

in the United States highlighting the

threat of emerging infections and

making specific recommendations to

address the threat. This report

emphasized a critical leadership role for

CDC in a national effort to detect and

control infectious disease threats.

In partnership with other Federal

agencies, State and local health

departments, academic institutions, and

others, CDC has developed a plan for

revitalizing the nation’s ability to

identify, contain, and prevent illness

from emerging infectious diseases. The

plan, Addressing Emerging Infectious

Disease Threats; A Prevention Strategy

for the United States, includes applied

research as a major objective, stressing

the importance of integrating laboratory

science and epidemiology to optimize

public health practice in the U.S. CDC

has developed an Extramural Applied

Research Program in Emerging

Infections (EARP) designed to fill gaps

in existing support for research in

emerging infectious disease

surveillance, epidemiology, and

prevention. This announcement

specifically addresses the correlation of

environmental monitoring of microbial

agents with disease control.

The microorganisms present in the

environment have played a role in the

transmission of infectious diseases.

Legionella, Cryptosporidia, Cyclospora,

Aspergillus, and vancomycin-resistant

enterococci are just a few examples of

agents with public health significance.

There are very few situations where the

results of environmental monitoring

have been correlated with disease

control. A good example of a situation

where correlation has been done is the

microbial quality of water and dialysate

in hemodialysis units. Here it has long

been established that once bacteria (and

in some instances endotoxin) go above

certain concentrations (2,000 CFU/ml in

dialysate, 200 CFU/ml in water, or 5

EU/ml in water used to reprocess

hemodialyzers) the risk of patients

developing bacteremia or a ‘‘pyrogenic’’

reaction during dialysis increases

substantially. However, the correlation

of environmental monitoring of

microbial agents with disease control in

other situations is unclear.

Legionnaires’ disease (LD) occurs

when an aerosol of water containing

Legionella spp. is inhaled. There are

8,000–18,000 cases of LD that occur

each year in the U.S., and 23 percent of

case-patients reported to the CDC

appear to have acquired the infection in

a health-care facility. Recent

investigations have demonstrated that

nosocomial transmission from colonized

hot water systems can occur for years or

even decades unless the illness is

recognized and the organism is

eradicated. Case-fatality rates among

patients with nosocomial LD may reach

> 30 percent, particularly in

immunocompromised individuals. In

1997, a survey of 253 National

Nosocomial Infections Surveillance

System (NNIS) hospitals indicated that

31 percent have identified cases of

nosocomial LD since 1990 and in 41

percent of hospitals legionellae were

recovered from the potable water

systems. However, many hospitals with

cases had done little to reduce

colonization and prevent further

transmission. Current CDC guidelines

only state that an environmental

investigation and intervention should be

done after nosocomial cases are

identified.

Vancomycin-resistant enterococci

(VRE) were first reported in 1989 and

have increased rapidly in incidence and

prevalence in the interim. At 189

hospitals reporting to the NNIS system,

the percentage of enterococcal isolates

from all body sites that were resistant to

vancomycin increased from 0.3 percent

in 1989 to 10.5 percent in 1995.
Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 / Notices 36917

Numerous hospital VRE outbreaks have

been reported and contamination of

environmental surfaces (e.g., bed rails,

countertops) with VRE has been

documented. Since VRE may survive

routine cleaning and disinfection

procedures, contamination of

environmental surfaces may contribute

to nosocomial transmission of VRE.

There is a need to document the extent

of environmental contamination with

this organism, the extent to which such

contamination contributes to

nosocomial transmission, and the

cleaning/disinfection procedures

necessary to remove VRE.

Invasive aspergillosis is a threat to

patients with compromised macrophage

or neutrophil function (i.e., patients

with neutropenia, receiving high-dose

corticosteroid therapy) or with

underlying chronic lung disease.

Aspergillus spp., are ubiquitous and are

routinely isolated from tap water, soil,

decaying vegetation, wet paint, food,

dust, and even sanitizing agents used in

hospitals. Several outbreaks of

aspergillosis have occurred during

periods of construction in and around

hospitals. Current recommendations are

directed at controlling the production of

aerosols during these periods.

Additionally, there is evidence that

higher aspergillosis spore counts

contribute to higher rates of invasive

disease among immunocompromised

patients. However, there is not

consensus about whether there should

be a benchmark spore count or on the

best methods to purify air.

Outbreaks of child-care-associated

illness may be caused by many different

agents and involve several different

modes of transmission. The

environment can play an important role

in these outbreaks. Most environmental

studies in child care settings have

focused on enteric diseases. Toys and

surfaces become contaminated either

directly or indirectly by feces and body

secretions from ill children. The

incidence of diarrhea has been

associated with isolation of fecal

coliforms from hands of children and

staff and from various environmental

surfaces in child-care centers. Levels of

environmental fecal coliforms have also

been linked with diaper type and the

use of over clothing in classes of nontoilet-trained children in child-care

centers. Cytomegalovirus has also been

isolated from hands and toys in a

classroom with a high prevalence of

infected children. Although respiratory

infections account for the majority of

illness episodes among children in

child-care facilities, relatively little

work has been done on the

environmental aspects of these

infections.

The relationship between results of

environmental monitoring of microbial

agents and the risk of infection from

these agents in the environment remains

largely undefined. In addressing this

issue, it is necessary to consider the

following requirements for

environmental transmission of disease

to take place: (1) presence of a microbial

agent in the environment, (2) the

organism must have sufficient

virulence, (3) relatively high numbers of

organisms, (4) mechanism of

transmission from the environment to

the host, (5) a successful portal of entry,

and (6) a susceptible host.

Purpose

The purpose of the EARP is to provide

financial and technical assistance for

applied research projects on emerging

infections in the U.S. As a component

of EARP, the purpose of this grant/

cooperative agreement announcement is

to provide assistance for one or more

projects addressing the correlation of

environmental monitoring of microbial

agents with disease control.

Environmental monitoring may play an

important role in infectious disease

control. However, additional studies are

needed to correlate results of

environmental monitoring with human

disease. Examples of areas needing

attention include, but are not limited to,

Legionella and Cryptosporidia in water,

Aspergillus spores in air, vancomycinresistant enterococci and other agents in

hospital and child-care environments.

Where appropriate, projects proposed

may include interventions to evaluate

detection methods.

Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the activities

under A. (Recipient Activities), and

CDC will be responsible for conducting

activities under B. (CDC Activities)

under cooperative agreements:

A. Recipient Activities

1. Identify a microbial agent of

increasing public health importance that

has a known environmental reservoir

(air, water, etc).

2. Conduct surveillance for human

infections in a particular setting, e.g.,

child-care facilities, health-care

facilities (hospitals, clinics, long-term

care facilities), etc.

3. Define the relationship between

finding the target organism in the

environment and the risk of human

disease in the target setting.

4. If feasible, determine the cost

effectiveness of different options for

microbial detection and disease control;

determine interventions where

appropriate.

5. Publish and/or otherwise

disseminate study findings.

B. CDC Activities (Cooperative

Agreements)

1. Provide technical assistance in the

design and conduct of the research.

2. Perform selected laboratory tests, as

appropriate and necessary.

3. Participate in data management, the

analysis of research data, and the

interpretation and presentation of

research findings.

4. Provide biological materials (e.g.,

strains, reagents, etc.) as necessary for

studies.

Technical Reporting Requirements

Narrative progress reports are

required semiannually. The first

semiannual report is required with the

first noncompeting continuation

application and should cover program

activities from date of award. The

second semiannual report is due 90

days after the end of each budget period

and should cover activities from the

date of previous report. Progress reports

should summarize tasks completed,

problems encountered, and plans for

continued research activities. Reports

should also include copies of any

publications resulting from the project.

An original and two copies of a

Financial Status Report (FSR) are

required not later than 90 days after the

end of each budget period.

A final performance report and FSR

are due not later than 90 days after the

end of the project period. All reports are

to be submitted to the Grants

Management Branch, CDC.

Application

1. Pre-application Letter-of-Intent

In order to enable CDC to plan the

review of applications submitted under

this Program Announcement, all parties

intending to submit application(s) are

requested to inform CDC of their

intention to do so as soon as possible

but not later than 30 business days prior

to the application due date. Notification

should include: (1) this program

announcement number (99005), (2)

name and address of institution, and (3)

name, address, and phone number of

contact person. Notification can be

provided by Facsimile, postal mail, or

electronic mail (E-mail) to: Matthew

Arduino, Dr. P.H., National Center for

Infectious Diseases, Centers for Disease

Control and Prevention (CDC) 1600
36918 Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 / Notices

Clifton Road, NE., Mailstop C–1,

Atlanta, GA 30333, Facsimile (404) 639–

3822, E-mail mja4@cdc.gov.

2. Application Content

Applicants are strongly encouraged to

develop applications in accordance with

PHS Form 398 information contained in

this grant/cooperative agreement

announcement, and the instructions

outlined below.

The original and five (5) complete

copies of the application must be

UNSTAPLED and UNBOUND. ALL

pages must be clearly numbered, and a

complete index to the application and

its appendices must be included. All

typewritten materials must be singlespaced, using a font no smaller than size

12. All supplemental pages of the

application (i.e., in addition to the 398

forms) must be on the 81⁄2′′ by 11′′ white

paper. All pages must be printed on

ONE side only, with at least 1′′ margins,

headers, and footers.

The application narrative must not

exceed 12 pages (excluding budget and

appendices). Unless indicated

otherwise, all information requested

below must appear in the narrative.

Materials or information that should be

part of the narrative will not be accepted

if placed in the appendices. The

application narrative must contain the

following sections in the order

presented below:

a. Abstract

Provide a brief (two pages maximum)

abstract of the project. Clearly identify

the project period proposed (not to

exceed maximum of 3 years as indicated

in Availability of Funds Section).

Clearly identify the type of award that

is being applied for, grant or cooperative

agreement.

b. Background and Need

Discuss the background and need for

the proposed project. Demonstrate a

clear understanding of the purpose and

objectives of this program

announcement. Discuss and

demonstrate how the proposed project

addresses an important gap which is of

public health importance.

c. Capacity and Personnel

Describe applicant’s past experience

in conducting activities similar to that

being proposed. Describe applicant’s

resources, facilities, and professional

personnel that will be involved in

conducting the project. Clearly identify

specific assigned responsibilities for all

key professional personnel. Include in

an appendix curriculum vitae for all

professional personnel involved with

the project. Describe plans for

administration of the project and

identify administrative resources/

personnel that will be assigned to the

project. Provide in an appendix letters

of support from all key participating

non-applicant organizations,

individuals, etc. (if any), which clearly

indicate their commitment to participate

as described in the operational plan. (Do

not include letters of support from CDC

personnel—they will not be accepted.)

d. Objectives and Technical Approach

Present specific objectives for the

proposed project which are measurable

and time-phased and are consistent with

the Purpose and Program Requirements

(Recipient Activities) sections of this

announcement. Present a detailed

operational plan for initiating and

conducting the project which clearly

and appropriately addresses these

objectives (if proposing a multi-year

project, provide a detailed description

of first-year activities and a brief

overview of subsequent-year activities).

Include a clear description of

applicant’s technical approach/methods

which are directly relevant to the above

objectives. Describe specific study

protocols or plans for the development

of study protocols. Describe the nature

and extent of collaboration with CDC (if

proposing a cooperative agreement)

and/or others during various phases of

the project. Describe in detail a plan for

evaluating progress toward achieving

process and outcome project objectives.

If the project will employ a particular

research subject population, describe

characteristics of the patient population

and how research in this subject group

will yield generalizable information.

Describe contingency plans which

acknowledge how the project will

address likely obstacles and assure that

the proposed task(s) can still be

completed. Include sample size

calculations where appropriate to assure

that measurable objectives can be

evaluated.

e. Budget

Provide a line-item budget and

accompanying detailed, line-by-line

justification for the first year of the

project that demonstrates the request is

consistent with the purpose and

objectives of this program. If requesting

a multi-year project, provide estimated

total budget (direct plus indirect) for

subsequent years. If requesting funds for

any contracts, provide the following

information for each proposed contract:

(1) Name of proposed contractor, (2)

breakdown and justification for

estimated costs, (3) description and

scope of activities to be performed by

contractor, (4) period of performance,

and (5) method of contractor selection

(e.g., sole-source or competitive

solicitation).

f. Human Subjects

Whether or not exempt from DHHS

regulations, if the proposed project

involves human subjects, describe in an

appendix adequate procedures for the

protection of human subjects. Also,

ensure that women, racial and ethnic

minority populations are appropriately

represented in applications for research

involving human subjects.

Evaluation Criteria

Applications will be reviewed and

evaluated according to the following

criteria:

1. Background and Need (15 Points)

Extent to which applicant

demonstrates a clear understanding of

the background, purpose, and objectives

of the project and the extent to which

the proposed project addresses an area

of public health importance not

adequately addressed in ongoing

programs.

2. Capacity (30 Points)

Extent to which applicant describes

adequate resources and facilities (both

technical and administrative) for

conducting the project. Extent to which

applicant documents that professional

personnel involved in the project are

qualified and have past experience and

achievements in research related to that

proposed as evidenced by curriculum

vitae, publications, etc. Extent to which

applicant clearly identifies specific

assigned responsibilities of all key

professional personnel. If applicable,

extent to which applicant includes

letters of support from non-applicant

organizations, individuals, etc., and the

extent to which such letters clearly

indicate the author’s commitment to

participate as described in the

operational plan.

3. Objectives and Technical Approach

(55 Points Total)

a. Extent to which applicant describes

objectives of the proposed project which

are consistent with the purpose of this

announcement and which are

measurable and time-phased. (15 points)

b. Extent to which applicant presents

a detailed operational plan for initiating

and conducting the project which

clearly and appropriately addresses all

Recipient Activities. Extent to which the

plan clearly describes applicant’s

technical approach/methods for

conducting the proposed studies and

extent to which the approach/methods

are appropriate and adequate to
Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 / Notices 36919

accomplish the objectives. Extent to

which applicant describes specific

study protocols or plans for the

development of study protocols that are

appropriate for achieving project

objectives. Extent to which applicant

describes adequate and appropriate

collaboration with CDC (if proposing a

cooperative agreement) and/or others

during various phases of the project. If

the proposed project involves human

subjects, whether or not exempt from

the HHS regulations, the extent to

which adequate procedures are

described for the protection of human

subjects, and the extent that women,

racial and ethnic minority populations

are appropriately represented in

applications involving human research.

(35 points)

c. Extent to which applicant provides

a detailed and adequate plan for

evaluating progress toward achieving

project process and outcome objectives.

(5 points)

4. Budget (Not Scored)

Extent to which the proposed budget

is reasonable, clearly justifiable, and

consistent with the intended use of

grant/cooperative agreement funds.

Executive Order 12372 Review

This program is not subject to

Executive Order 12372 Review.

Public Health System Reporting

Requirements

This program is not subject to the

Public Health System Reporting

Requirements.

Catalog of Federal Domestic Assistance

Number

The Catalog of Federal Domestic

Assistance Number is 93.283.

Other Requirements

Paperwork Reduction Act

Projects that involve the collection of

information from ten or more

individuals and funded by the grant/

cooperative agreement will be subject to

review by the Office of Management and

Budget (OMB) under the Paperwork

Reduction Act.

Human Subjects

If the proposed project involves

research on human subjects, the

applicant must comply with the

Department of Health and Human

Services Regulations (45 CFR Part 46)

regarding the protection of human

subjects. Assurance must be provided to

demonstrate that the project will be

subject to initial and continuing review

by an appropriate institutional review

committee. The applicant will be

responsible for providing evidence of

this assurance in accordance with the

appropriate guidelines and form

provided in the application kit.

In addition to other applicable

committees, Indian Health Service (IHS)

institutional review committees also

must review the project if any

component of IHS will be involved or

will support the research. If the Native

American community is involved, its

tribal government must also approve

that portion of the project applicable to

it.

Women, Racial and Ethnic Minorities

It is the policy of the CDC and the

Agency for Toxic Substances and

Disease Registry (ATSDR) to ensure that

individuals of both sexes and the

various racial and ethnic groups will be

included in CDC/ATSDR-supported

research projects involving human

subjects, whenever feasible and

appropriate. Racial and ethnic groups

are those defined in OMB Directive No.

15 and include American Indian or

Alaska Native, Asian, Black or African

American, Hispanic or Latino, Native

Hawaiian or Other Pacific Islander.

Applicants shall ensure that women,

racial and ethnic minority populations

are appropriately represented in

applications for research involving

human subjects. Where clear and

compelling rationale exist that inclusion

is inappropriate or not feasible, this

situation must be explained as part of

the application. This policy does not

apply to research studies when the

investigator cannot control the race,

ethnicity, and/or sex of subjects. Further

guidance to this policy is contained in

the Federal Register, Vol. 60, No. 179,

pages 47947–47951, and dated Friday,

September 15, 1995.

Animal Subjects

If the proposed project involves

research on animal subjects, the

applicant must comply with the ‘‘PHS

Policy on Humane Care and Use of

Laboratory Animals by Awardee

Institutions.’’ An applicant organization

proposing to use vertebrate animals in

PHS-supported activities must file an

Animal Welfare Assurance with the

Office for Protection from Research

Risks at the National Institutes of

Health.

Application Submission and Deadline

The original and five complete copies

of each application PHS Form 398 must

be submitted to Sharron P. Orum,

Grants Management Officer, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300,

Mailstop E–18, Atlanta, GA 30305, on or

before October 1, 1998.

1. Deadline: Applications shall be

considered as meeting the deadline if

they are either:

a. Received on or before the deadline

date; or

b. Sent on or before the deadline date

and received in time for submission to

the objective review group. (Applicants

must request a legibly dated U.S. Postal

Service postmark or obtain a legibly

dated receipt from a commercial carrier

or U.S. Postal Service. Private metered

postmarks shall not be acceptable as

proof of timely mailing.)

2. Late Applications: Applications

which do not meet the criteria in 1.a. or

1.b. above are considered late

applications. Late applications will not

be considered and will be returned to

the applicant.

Where To Obtain Additional

Information

To receive additional written

information and to request an

application kit, call 1–888–GRANTS

(1–888 472–6874). You will be asked to

leave your name and address and will

be instructed to identify the

announcement number of interest.

(Please refer to Announcement Number

99005.) You will receive a complete

program description, information on

application procedures and application

forms.

If you have questions after reviewing

the contents of all the documents,

business management technical

assistance may be obtained from Oppie

M. Byrd, Grants Management Specialist,

Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road, NE.,

Room 314, Mailstop E–18, Atlanta, GA

30305, telephone (404) 842–6546,

Facsimile (404) 842–6513, Internet

oxb3@cdc.gov.

Programmatic technical assistance

may be obtained from Matthew J.

Arduino, M.S., Dr.P.H., National Center

for Infectious Diseases, Hospital

Infections Program, Centers for Disease

Control and Prevention (CDC), 1600

Clifton Road, NE., Mailstop C–01,

Atlanta, GA 30333, telephone (404)

639–2318, Internet mja4@cdc.gov.

You may obtain this announcement

from one of two Internet sites on the

actual publication date: CDC’s

homepage at http://www.cdc.gov or at

the Government Printing Office

homepage (including free on-line access

to the Federal Register at http://

www.access.gpo.gov).
36920 Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 / Notices

Potential applicants may obtain a

copy of Healthy People 2000 (Full

Report, Stock No. 017–001–00474–0) or

Healthy People 2000 (Summary Report,

Stock No. 017–001–00473–1) referenced

in the Introduction through the

Superintendent of Documents,

Government Printing Office,

Washington, D.C. 20402–9325,

telephone: (202) 512–1800.

Dated: July 1, 1998.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 98–18017 Filed 7–7–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention (CDC)

[Announcement 98043]

National Partnership for Human

Immunodeficiency; Virus (HIV)

Prevention; Notice of Availability of

Funds for Fiscal Year 1998

Amendment

A notice announcing the availability

of Fiscal Year 1998 funds for grants to

support National Partnerships for

Human Immunodeficiency Virus (HIV)

Prevention Program was published in

the Federal Register on June 3, 1998,

[Vol. 63 FR No. 106]. The notice is

amended as follows:

On page 30233, third column, under

‘‘Eligible Applicants’’, the first

paragraph, line 12 should read: ‘‘Taxexempt status is determined by the

Internal Revenue Service (IRS) Code,

Section 501(c). Tax-exempt status may

be proved by either providing a copy of

the pages from the IRS’ most recent list

of 501 (c) tax-exempt organizations or a

copy of the current IRS Determination

Letter.’’

On page 30238, second column, under

‘‘Submission and Deadline’’, the second

paragraph should read: ‘‘On or before

August 7, 1998, submit the application

to: Julia Valentine Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office,

Announcement 98043, Centers for

Disease Control and Prevention (CDC),

Room 300, 255 East Paces Ferry Road,

NE, M/S E15, Atlanta, GA 30305–2209.

All other information and

requirements of the notice remain the

same.

Dated: July 1, 1998.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 98–18015 Filed 7–7–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 98085]

Young People in Alternative Education

Settings: Preventing HIV and Other

Sexually Transmitted Diseases Notice

of Availability of Fiscal Year 1998

Funds; Amendment

A notice announcing the availability

of fiscal year (FY) 1998 funds for

cooperative agreements for the

prevention of human immunodeficiency

virus (HIV), and other sexually

transmitted diseases (STDs) among

young people in alternative educational

settings was published in the Federal

Register on June 24, 1998, [Vol. 63 FR

Number 121]. The notice is amended as

follows:

On page 34432, third column, under

‘‘Application Submission and

Deadline’’, the second paragraph should

read: ‘‘An original and two copies of the

application PHS Form 5161–1 (Revised

5/96, OMB Number 0937–0189) must be

submitted to Sharron P. Orum, Grants

Management Officer, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), Room

300, Mail Stop E–18, 255 East Paces

Ferry Road, NE., Atlanta, GA 30305, on

or before August 15, 1998.’’

All other information and

requirements of the notice remain the

same.

Dated: July 01, 1998.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 98–18023 Filed 7–7–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Advisory Committees; Filing of Annual

Reports

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that, as required by the Federal

Advisory Committee Act, the agency has

filed with the Library of Congress the

annual reports of those FDA advisory

committees that held closed meetings

during fiscal year 1995, 1996, and 1997.

FDA apologizes for the lateness in the

filing of these reports due to

circumstances beyond the agency’s

control.

ADDRESSES: Copies are available from

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852, 301–443–1751.

FOR FURTHER INFORMATION CONTACT:

Donna M. Combs, Committee

Management Office (HFA–306), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

4820.

SUPPLEMENTARY INFORMATION: Under

section 13 of the Federal Advisory

Committee Act (5 U.S.C. app. 2) and 21

CFR 14.60(c), FDA has filed with the

Library of Congress the annual reports

for the following FDA advisory

committees that held closed meetings

during the period October 1, 1994,

through September 30, 1995:

Center for Biologics Evaluation and

Research:

Allergenic Products Advisory

Committee,

Biological Response Modifiers

Advisory Committee,

Blood Products Advisory Committee,

Vaccines and Related Biological

Products Advisory Committee.

Center for Drug Evaluation and

Research:

Anesthetic and Life Support Drugs

Advisory Committee,

Anti-Infective Drugs Advisory

Committee,

Antiviral Drugs Advisory Committee,

Arthritis Advisory Committee,

Drug Abuse Advisory Committee,

Endocrinologic and Metabolic Drugs

Advisory Committee,

Generic Drugs Advisory Committee,

Medical Imaging Drugs Advisory

Committee,

Nonprescription Drugs Advisory

Committee,

Oncologic Drugs Advisory Committee.

Center for Devices and Radiological

Health:

Medical Devices Advisory Committee

(consisting of reports for the

Anesthesiology and Respiratory

Therapy Devices Panel; Circulatory

System Devices Panel; Clinical

Chemistry and Clinical Toxicology